Effect of Uterine Manipulator on Recurrence and Mortality of Endometrial Cancer

Effect of Uterine Manipulator on Recurrence and Mortality of Endometrial Cancer: a Multi-centric Study

The investigators sought to retrospectively assess whether the use of a intrauterine device to manipulate the uterus does affect the long-term oncologic outcomes of patients operated by laparoscopy for endometrial cancer

Study Overview

• Status: Completed
• Conditions: Endometrial Cancer
• Intervention / Treatment: Device: UTERINE MANIPULATOR

Detailed Description

The investigators retrospectively collected data regarding patients who received operation by laparoscopy for presumed clinical stage I endometrial cancer. The subjects were then stratified according to the use or not of the uterine manipulator. The investigators also considered the actual type of manipulator used. Then disease-free, disease-specific and overall survival were evaluated, as well as all the possible factors associated with prognosis.

Data were retrieved from specifically designed research quality internal surgical databases, prospectively updated by trained residents on a regular basis, in order to capture all the possible surgical and follow-up data.

• Study Type: Observational
• Enrollment (Actual): 951

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women affected by early endometrial cancer

Description

Inclusion Criteria:

• Clinical stage I endometrial cancer
• Laparoscopic operation

Exclusion Criteria:

• post-operative oncologic follow-up < 12 months
• extra-uterine evidence of disease

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MANIPULATOR; Patients who were operated for endometrial cancer by laparoscopy with the use of a uterine manipulator	Device: UTERINE MANIPULATOR; Patients were operated laparoscopically with the aid or not of an intrauterine probe to manipulate the uterus
NO MANIPULATOR; Patients who were operated for endometrial cancer by laparoscopy without the use of a uterine manipulator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease recurrence	Relapse of disease during follow-up	4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
disease specific survival	Kaplan Meyer curves and Log-rank test to explore disease-specific survival	4 years
overall survival	Kaplan Meyer curves and Log-rank test to explore overall survival	4 years

Collaborators and Investigators

• Sponsor: Università degli Studi dell'Insubria
• Investigators: Principal Investigator: Stefano Uccella, Università degli Studi dell'Insubria

Publications and helpful links

General Publications

• Marcos-Sanmartin J, Lopez Fernandez JA, Sanchez-Paya J, Pinero-Sanchez OC, Roman-Sanchez MJ, Quijada-Cazorla MA, Candela-Hidalgo MA, Martinez-Escoriza JC. Does the Type of Surgical Approach and the Use of Uterine Manipulators Influence the Disease-Free Survival and Recurrence Rates in Early-Stage Endometrial Cancer? Int J Gynecol Cancer. 2016 Nov;26(9):1722-1726. doi: 10.1097/IGC.0000000000000808.
• Tinelli R, Cicinelli E, Tinelli A, Bettocchi S, Angioni S, Litta P. Laparoscopic treatment of early-stage endometrial cancer with and without uterine manipulator: Our experience and review of literature. Surg Oncol. 2016 Jun;25(2):98-103. doi: 10.1016/j.suronc.2016.03.005. Epub 2016 Mar 23.

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: October 22, 2016
• First Submitted That Met QC Criteria: October 22, 2016
• First Posted (Estimate): October 25, 2016

Study Record Updates

• Last Update Posted (Estimate): November 15, 2016
• Last Update Submitted That Met QC Criteria: November 14, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: endometrial cancer; survival; uterine manipulator
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Disease Attributes; Recurrence; Endometrial Neoplasms
• Other Study ID Numbers: 521

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO